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CompletedNCT01545453Updated Nov 2, 2016

A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)

A Phase 2 interventional study of lebrikizumab and lebrikizumab in Asthma, sponsored by Genentech, Inc.. Completed at 64 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 205 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients, 18 to 75 years of age at Visit 1
  • Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)
  • Bronchodilator response during screening
  • Pre-bronchodilator FEV1 40%-80% of predicted during screening
  • On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for >/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
  • On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
  • Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
  • Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
  • Demonstrated adherence with controller medication during the screening period

Exclusion criteria

Exclusion Criteria:

  • History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of zileuton or roflumilast within 6 months prior to screening
  • Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
  • Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
  • Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
  • Active parasitic infection within the 6 months prior to Visit 1
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Known immunodeficiency, including, but not limited to, HIV infection
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
  • Known malignancy or current evaluation for a potential malignancy
  • Current smoker or former smoker with a history >10 pack years
  • History of alcohol, drug or chemical abuse
  • Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
  • Use of biologic therapy including omalizumab during 6 months prior to Visit 1
  • Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
  • Pregnant or lactating women
  • Body mass index (BMI) > 38 kg/m2
  • Body weight \< 40 kg
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
205 participants (actual)

Study arms

  • Experimental
    lebrikizumab - highest dose

    Drug: lebrikizumab

  • Experimental
    lebrikizumab - lowest dose

    Drug: lebrikizumab

  • Experimental
    lebrikizumab - middle dose

    Drug: lebrikizumab

  • Placebo comparator
    placebo

    Drug: placebo

Interventions

  • Druglebrikizumab

    subcutaneous dose every 4 weeks

  • Druglebrikizumab

    subcutaneous dose every 4 weeks

  • Druglebrikizumab

    subcutaneous dose every 4 weeks

  • Drugplacebo

    subcutaneous dose every 4 weeks

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What researchers measure

Primary outcomes

  1. Rate of asthma exacerbations during the 52-week placebo-controlled period

    Time frame: weeks 0-52

Secondary outcomes

  1. Change in lung function: pre-bronchodilator FEV1

    Time frame: from baseline to week 52

  2. Time to first asthma exacerbation

    Time frame: from baseline to week 52

  3. Change in fractional exhaled nitric oxide (FeNO)

    Time frame: from baseline to week 52

  4. Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])

    Time frame: from baseline to week 52

  5. Change in asthma rescue medication use

    Time frame: from baseline to week 52

  6. Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period

    Time frame: from baseline to week 52

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Study locations

64 sites
  • Oxford, Alabama 36203-7190, United States
  • Long Beach, California 90808, United States
  • Los Angeles, California 90025, United States
  • Orange, California 92868, United States
  • Redwood City, California 94063, United States
  • San Mateo, California 94401, United States
  • Stockton, California 95207, United States
  • Centennial, Colorado 80112, United States
  • Colorado Springs, Colorado 80907, United States
  • Kissimmee, Florida 34741, United States
  • Miami, Florida 33173, United States
  • Panama City, Florida 32405, United States
  • Columbus, Georgia 31904, United States
  • Decatur, Georgia 30033, United States
  • Woodstock, Georgia 30188, United States
  • Twin Falls, Idaho 83301, United States
  • Normal, Illinois 61761, United States
  • Indianapolis, Indiana 46208, United States
  • Lafayette, Indiana 47904, United States
  • Overland Park, Kansas 66210, United States
  • Baltimore, Maryland 21236, United States
  • Brockton, Massachusetts 02301, United States
  • Bay City, Michigan 48706, United States
  • Novi, Michigan 48375, United States
  • Ypsilanti, Michigan 48197, United States
  • Minneapolis, Minnesota 55402, United States
  • Plymouth, Minnesota 55441, United States
  • Chesterfield, Missouri 63017, United States
  • Saint Louis, Missouri 63141, United States
  • St Louis, Missouri 63141, United States
  • Missoula, Montana 59808, United States
  • Omaha, Nebraska 68130, United States
  • Brick, New Jersey 08724, United States
  • Edison, New Jersey 08820, United States
  • Ocean, New Jersey 07712, United States
  • Teaneck, New Jersey 07666, United States
  • Verona, New Jersey 07044, United States
  • North Syracuse, New York 13212, United States
  • Canton, Ohio 44718, United States
  • Centerville, Ohio 45458, United States
  • Cincinnati, Ohio 45242, United States
  • Toledo, Ohio 43617, United States
  • Oklahoma City, Oklahoma 73120, United States
  • Tulsa, Oklahoma 74136, United States
  • Medford, Oregon 97504, United States
  • Altoona, Pennsylvania 16601, United States
  • Hershey, Pennsylvania 17033, United States
  • Philadelphia, Pennsylvania 19107, United States
  • Pittsburgh, Pennsylvania 15241, United States
  • Pittsburg, Pennsylvania PA, United States
  • Sellersville, Pennsylvania 18960, United States
  • Columbia, South Carolina 29201, United States
  • Greenville, South Carolina 29615, United States
  • Austin, Texas 78750, United States
  • Austin, Texas 78759, United States
  • Boerne, Texas 78006, United States
  • El Paso, Texas 79903, United States
  • Houston, Texas 77030, United States
  • Sugar Land, Texas 77479, United States
  • Murray, Utah 84107, United States
  • Fairfax, Virginia 22030, United States
  • Spokane, Washington 99204, United States
  • Madison, Wisconsin 53715, United States
  • Brisbane, Queensland 4075, Australia
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References and documents

Publications

  • Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7. PubMed 33217063 ↗
  • Hanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, Cheu M, Putnam WS, Murray E, Scheerens H, Holweg CT, Maciuca R, Gray S, Doyle R, McClintock D, Olsson J, Matthews JG, Yen K. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015 Aug;70(8):748-56. doi: 10.1136/thoraxjnl-2014-206719. Epub 2015 May 22. PubMed 26001563 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01545453
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Mar 6, 2012
Start date
Mar 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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